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Relmada Therapeutics

HQ: Coral Gables, FL source · relmada.com ↗ · Southeast

Clinical Phase 3

Keywords: non-muscle invasive bladder cancer Prader-Willi syndrome Bladder (Urothelial, Transitional Cell) Cancer Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive) Urothelial Carcinoma Bladder Urologic Cancer Major Depressive Disorder Urothelial Carcinoma Recurrent Neuropathic Pain Depression Treatment-Resistant Depressive Disorder REL-1017

Location: Coral Gables, FL · source · Oct 15, 2026

Profile checked Oct 10, 2026

$260.0MRaised (2 yrs)11Trials (company is sponsor)

Timeline

  1. Trial start Phase 3: A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer source ↗
  2. Trial start Phase 3: A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy source ↗
  3. Trial start Phase 3: A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT source ↗
  4. Raise Private placement: $160M (total, as published), announced Mar 9, 2026. Source: SEC filing. source ↗
  5. Raise Follow-on offering: $100M (total, as published), announced Nov 4, 2025. Source: company release on GlobeNewswire. source ↗
  6. Trial start Phase 2: A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC source ↗
  7. Trial start Phase 3: A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD) source ↗
  8. Trial start Phase 3: Safety of REL-1017 for Major Depressive Disorder source ↗
  9. Trial start Phase 3: A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) source ↗
  10. Trial start Phase 2: Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD source ↗
  11. Trial start Phase 1: Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone) source ↗
  12. Trial start Phase 1: Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone) source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Raised: $260.0M. Last 2 years.

Clinical trials (lead sponsor) 11

RecordTitlePhaseStatusStartPrimary completion
NCT06663137A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBCPhase 2RecruitingAug 1, 20242027-11 (estimated)
NCT07464145A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder CancerPhase 3Not yet recruiting2027-022029-12 (estimated)
NCT06009003Individual Patient Esmethadone (REL-1017) Expanded Access ProgramNot listedNo longer availableNot listedNot listed
NCT07342517A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line TherapyPhase 3WithdrawnJun 30, 2026Jun 30, 2027 (estimated)
NCT07313891A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBTPhase 3WithdrawnMay 1, 2026Sep 1, 2029 (estimated)
NCT04855760Safety of REL-1017 for Major Depressive DisorderPhase 3CompletedApr 1, 2021Jul 27, 2023 (actual)
NCT04688164A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)Phase 3CompletedJan 8, 2021Nov 1, 2022 (actual)
NCT05081167A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)Phase 3CompletedJun 2, 2021Sep 13, 2022 (actual)
NCT03051256Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDDPhase 2CompletedMay 11, 2018Jul 30, 2019 (actual)
NCT03637361Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of REL-1017 (d-Methadone)Phase 1CompletedDec 4, 2014Jun 2, 2015 (actual)
NCT03638869Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of REL-1017 (d-Methadone)Phase 1CompletedAug 31, 2015Nov 16, 2015 (actual)
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